Dose escalation will be continued until more than one-third of the patients in a given
cohort show dose-limiting toxicity (DLT) during treatment cycle 1. At least three patients
will be enrolled in each cohort. Before escalating to the next dose level, all three
patients should have received at least one treatment cycle. If none of the first three
treated patients develops DLT in the first cycle at a specific dose level, dose escalation
will be continued. If one of the first three treated patients develops DLT at any dose
level, then three additional patients are to be entered on the same dose level. If only one
in six patients at a given level experiences a DLT, escalation will proceed. The MTD is
defined as the dose level at which at least one-third of patients experienced a DLT. The RD
for the subsequent phase II study is defined as the preceding dose level before the MTD is
attained. Intra-patient dose escalation will not be permitted. Treatment will be continued
in the absence of disease progression or unacceptable toxicity with maximum 12 cycles. For
purpose of determining the MTD, only DLT occurring during the first cycle of therapy will be
considered.

DLTs are defined as any of following;

- Grade 4 neutropenia lasting at least 7 days or grade 3 or 4 neutropenia associated with
fever  38.3C as single axillary temperature or 38 C for 1-h

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